Jack J. Luchese: Book Available

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“The Life Science Entrepreneur: A Practical Guide to Forming, Financing, Building, and Exiting a Life Science Company“   Author: Jack J. Luchese, BA, MBA  – Contact Jack J. Luchese Available on Amazon: Paperback and Kindle Chapter 1. The Compelling Idea The The world still loves a great idea! One of the most important things to remember when… Read more »

AE and Protocol Deviation Logs

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Patrick R. Ayd, BSN, MBA Advisor: Clinical Sites FDA or ICH-GCP Guidelines I receive many questions regarding whether or not the FDA or ICH-GCP guidelines requires AE or Protocol Deviation logs for a clinical trial. As you all know, what the FDA expects is somewhat vague at best, it is my opinion that creating these… Read more »

BioAlliance Serves EU Clients to Align with US Sponsors and CROs

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Imen Jelassi, PharmD, MSc Advisor: EU Director Strategic Partnerships Contact Us For More Information  http://goo.gl/PV31NZ Imen Jelassi, PharmD, MSc, is building relationships between EU life science companies and the US. Her activities create opportunities for EU CROs, Pharma and Biotechs to align with US companies for strategic relationships in Business and Corporate Development, Web Design, Branding, Video… Read more »

The Changing Landscape of European Medical Device Regulations (part 3 of 3)

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The Changing Landscape of European Medical Device Regulations Patrick D. Mize, Ph.D.   Contact Dr. Mize  http://goo.gl/PV31NZ Advisor: Product Development / Regulatory Services Part 3 of 3 Pre-clinical and Performance Studies Pre-clinical and verification performance studies are usually summarized in the Technical File and a summary can be presented in the CER or the studies… Read more »

The Changing Landscape of European Medical Device Regulations (part 2 of 3)

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The Changing Landscape of European Medical Device Regulations Patrick D. Mize, Ph.D.   Contact Dr. Mize  http://goo.gl/PV31NZ Advisor: Product Development / Regulatory Services Introduction The Clinical Evaluation Report [CER] The CER, which is included in your Technical File or Design Dossier, is required when bringing a medical device to market and helps demonstrate that the… Read more »

The Critical Nature of SOP’s

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The Critical Nature of SOP’s It is critical that every clinical research facility have SOPs or Standard Operating Procedures. An SOP is a document that clearly defines/describes how a procedure or process is performed at your research facility. Standardizing procedures and processes is key to collecting correct, timely, and consistent data which is a goal… Read more »